Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

NOVARTIS HALTS DEVELOPMENT OF CHOLESTEROL-LOWERING DRUG

Novartis has terminated development of an experimental cholesterol-lowering
drug after clinical studies showed the treatment was not more effective than
existing medications.

Pulling the plug on NKS104 (pitavastatin), a lipid-lowering agent in Phase II
testing, will cost Novartis approximately $266 million, which will be booked
in the fourth quarter, the Swiss firm said recently. Novartis previously announced
in October it was "assessing" further development of pitavastatin
based on mixed trial results.

The decision to stop development of the drug did not come as a surprise to financial
analysts, who noted that clinical studies showed the drug might cause liver
abnormalities. "The risks had been reasonably flagged by management over
the last few months and this announcement shouldn't come as a complete surprise,"
analysts James Millett and Martin Brunninger of UK-based investment bank Cazenove
wrote in a recent research note.

Bob Pooler, an analyst with Zurich-based investment bank Lombard Odier Darier
Hentsch, offered similar comments, saying, "The discontinuation of NKS104
was widely anticipated due to the emergence of liver enzyme elevations and the
lack of a major clinical differentiation over AstraZeneca's superstatin Crestor."

The NKS104 news was one of two development setbacks for Novartis last week.
A European Medicines Agency (EMEA) advisory committee recently recommended against
approval of Zelnorm (tegaserod), a drug intended to treat irritable bowel syndrome
in women.

Although Zelnorm is already approved in the U.S., the EMEA's Committee for Medicinal
Products for Human Use concluded that the drug's benefits do not outweigh its
risks. Specifically, the EMEA advisers expressed concerns about the results
of Novartis' supporting clinical data, which they said would not translate into
real benefit for patients treated in a standard healthcare setting.